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NEUROCOG TRIALS INTRODUCES NCT PATHWAY: NEXT GENERATION eCOA FOR CLINICAL TRIALS – PRESS RELEASE

Innovative platform designed to deliver the highest quality of clinical data, streamline site processes, and improve patient experience

 

DURHAM, NORTH CAROLINA, JULY 13, 2017 – NeuroCog Trials (NCT), a clinical technology and research services company dedicated to supporting global drug development, announces the general availability of its new flagship eCOA platform, NCT Pathway. Developed with input from seasoned clinical investigators, Pathway has the dynamic technical capabilities and user-driven design to meet the needs of virtually any clinical trial, from Alzheimer’s disease and schizophrenia to oncology and cardiology.  The platform is currently in use by large sponsors in several late stage clinical trials.

“I am thrilled to be presenting Pathway to the clinical trials community. We have dedicated ourselves to creating a tool that has a beautifully simple user interface, rigorous attention to scientific and regulatory detail, and a seamless back-end data transfer and storage system,” said Co-Founder and CEO, Dr. Richard Keefe.

Other key benefits of NCT Pathway include: automated features and assisted scoring for improved protocol compliance, real-time data capture, central review portal, CDISC compliant storage and data transfer, and integrated security and regulatory compliance features. Recognized globally for expertise in clinical and cognitive measurement and data quality assurance, NeuroCog Trials implements rigorous testing and validation procedures to proactively anticipate challenges and ensure the highest level of performance across all its software solutions. NCT delivers innovative technology and science-driven data solutions with unrivaled dependability.

To learn more about NCT Pathway, please visit http:/www.neurocogtrials.com/products/pathway-ecoa/

About NeuroCog Trials

NeuroCog Trials (NCT) is a cognition and clinical assessment services and technology company devoted exclusively to applying rigorous standards for key endpoints in multi-site clinical trials in many different indications.  It has provided consulting, site screening, rater training and certification, translation, and data services for more than 100 clinical trials in over 25 countries.  Founded in 2005, NCT is a privately held, certified woman-owned business, headquartered in Durham, North Carolina.

Contact Jenna Piunti
Office +1 919 433 2429
Switchboard +1 919 401 4642
Email Jenna.piunti@neurocogtrials.com

Website www.neurocogtrials.com

View or download the press release in a PDF.

View the press release at PR Newswire.

Placebo Response and Practice Effects in Schizophrenia Cognition Trials

Questions:  What is the magnitude of learning effects in patients with schizophrenia receiving placebo on the criterion standard Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB), and can these learning effects be anticipated in individual patients?

Findings:  This blinded review of 12 trials including 813 patients with schizophrenia suggested that the mean change in the MCCB during receipt of placebo was less than 0.2 SDs, a small effect. Factors associated with greater improvements on the MCCB included more motivation, more depression/anxiety, and less improvement from screening to baseline.

Meaning: These changes in the MCCB are too small to be responsible for effective active treatments failing to separate from placebo.

View the article at Jama Psychiatry.

View or download the PDF.

Cognitive burden of anticholinergic medications in psychotic disorders

Patients with psychotic disorders are often treated with numerous medications, many of which have anticholinergic activity. We assessed cognition in relation to the cumulative anticholinergic burden of multiple drugs included in treatment regimens of participants from the Bipolar-Schizophrenia Network on Intermediate Phenotypes (B-SNIP) study.

Clinically stable participants with schizophrenia (n = 206), schizoaffective disorder (n = 131), and psychotic bipolar disorder (n = 146) were examined. Anticholinergic properties of all scheduled drugs were quantified using the Anticholinergic Drug Scale (ADS). ADS scores were summed across individual drugs to create a total ADS burden score for each participant and examined in relation to the Brief Assessment of Cognition in Schizophrenia (BACS).

View the full article at Schizophrenia Research

Cognitive Decline and Disrupted Cognitive Trajectory in Schizophrenia

Article in JAMA Psychiatry

One of the greatest challenges for the identification of the causes and cures for schizophrenia is the overwhelming heterogeneity of the disorder. Schizophrenia is defined by symptoms that have only weak associations with one another and are found in patients with other illnesses. Further, some of the most devastating symptoms, such as cognitive impairment and amotivation, are present in segments of the healthy general population.

Our inability to define sharp boundaries in the clinical presentation of the illness has hampered research efforts to identify treatments. There are no single genes of substantial effect that can identify patients, no clear biological markers, and, despite decades of research on the structure and function of the brains of these patients, no neuroanatomical abnormality that clearly distinguishes a person with schizophrenia from someone who is healthy.

The absence of clear boundaries among patients with severe mental illness has significant implications for treatment and treatment development. There are 23 antipsychotic medications approved for use in the United States, but there is precious little reliable information to determine which patients should receive which medication. And while our understanding of human neurobiology advances swiftly, if we have no biological means to separate those who will benefit from a treatment from those who will not, then clinical trials for new treatments will be challenged to succeed.

View or download the full article on JAMA Psychiatry

 

Assessing Functional Capacity using the UCSD Performance-based Skills Assessment (UPSA-2-VIM) and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

This poster was presented at the Annual Meeting of the American Society for Experimental NeuroTherapeutics (ASENT) 

15-17 March 2017
Washington DC/Rockville MD

Reliable measurement of functional capacity is critical in assessing the efficacy of treatments for cognitive impairment in a wide range of CNS disorders including
schizophrenia, mood disorders, mild cognitive impairment (MCI) and Alzheimer’s disease (AD). Despite FDA requirements for functional co-primary endpoints in clinical trials of cognitive enhancing therapies, development and standardization of these functional measures has lagged behind the equally critical cognitive endpoints. In order to optimize signal detection, measures of functional capacity must offer psychometric properties on par with cognitive endpoints. The present research assesses the relative sensitivity and psychometric reliability of two measures of functional capacity, the UCSD Performance based Skills Assessment (UPSA-2-VIM) and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT).

View or download the poster as a PDF

 

Validation of the Tablet-based Brief Assessment of Cognition (BAC App) for Schizophrenia

This poster was Presented at the Annual Meeting of the American Society for Experimental NeuroTherapeutics (ASENT) 

15-17 March 2017
Washington DC/Rockville MD

Computerized tests benefit from automated scoring procedures and standardized administrator instructions. These methods can reduce the potential for rater error.
However, especially in patients with severe mental illnesses and neurologic disorders, the equivalency of traditional and tablet-based tests cannot be assumed.
The Brief Assessment of Cognition in Schizophrenia (BACS) is a pen-and-paper cognitive assessment tool that has been used in hundreds of research studies and
clinical trials, and has normative data available for generating age- and gendercorrected standardized scores. A tablet-based version of the BACS called the BAC App
has been developed.

View or download the poster as a PDF

 

 

Validation of the tablet-administered Brief Assessment of Cognition (BAC App)

The validation study of our proprietary Brief Assessment of Cognition (BAC App) is now in press in Schizophrenia Research, available as Open Access PDF.

To facilitate the administration of our widely-used pen-and-paper neurocognitive battery, the Brief Assessment of Cognition (BAC), we developed a regulatory compliant iPad-based application, the BAC App. The purpose of the BAC App is to reduce administration burden on site raters by automating and standardizing the testing procedures and scoring, while maintaining the importance of the rater-patient interaction.

Ensuring full understanding of the task at hand, motivation to try their best, and providing general encouragement to complete the testing is critical to obtaining meaningful data in impaired or behaviorally-challenging patient populations such as Alzheimer’s Disease, depression, ADHD and schizophrenia. Audio recording also allows independent scoring and data quality checks, and provides insight into the testing session.

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BACapp

 For more information about the BAC App, navigate here.

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The validation study compared performance and psychometric characteristics of the BAC App with the original pen-and-paper BAC in patients with schizophrenia and healthy controls recruited from 3 US sites. The study confirms the equivalence of the mode of administration between the pen-and-paper BAC and BAC App for all subtests, except the Token Motor Test due to the expected qualitative differences in task demands.

Most importantly, the applicability of the established normative data is confirmed. The study showed that iPad-assisted rater administration using the BAC App is a viable option to reduce site burden while maintaining the validity of the neurocognitive outcomes. The BAC App is now being implemented in industry-sponsored clinical trials.

 

View or download a PDF.

View the publication at Schizophrenia Research.

Cultural Adaptation of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) for Use in the UK and Canada

The poster contains a discussion of methods for cross-cultural adaptation of performance-based outcome assessments:

  • Cultural adaptation of performance-based outcomes can improve the quality of these assessments by ensuring tasks, stimuli and instructions are understood
    and appropriate for use in populations of interest;
  • Use of culturally appropriate materials is especially important for tests of functional capacity, which assess an individual’s potential to function in culturally specific real world environments;
  • Description of cultural adaptation of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a computer-based assessment of functional capacity originally developed for the U.S.

View a PDF of the Poster.

 

Rasch Analysis to Test the Cross-Cultural Item Equivalence of the Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog)

Poster: Rasch Analysis to Test the Cross-Cultural Item Equivalence of the Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog)

Introduction: Bias is a significant challenge to the validity of cognitive tests. Differential item functioning (DIF) is present when different groups have differing responses on test items, after controlling for overall ability. Differential Item Functioning (DIF) investigates the items in a test, one at a time, for signs of interactions with sample characteristics. Item functioning is intended to be invariant with respect to aspects of the participants, such as gender, ethnicity and cultural status. The DIF analysis for one item is as independent as possible of the DIF analyses of the other items. But a consequence is that the overall impact of item DIF, accumulated cross the whole test, is unclear.

See the entire poster in a PDF.

IOM Neuroscience Trials of the Future (Second Update)

Neuroscience Trials of the Future

UPDATE SEPTEMBER 8, 2016: The prepublication of 

Neuroscience Trials of the Future: Proceedings of a Workshop

is now available online at the National Academies Press.

UPDATE APRIL 5, 2016: Presentations are now available for review at Neuroscience Trials of the Future: A Workshop (Click on Presentations at top right)

Institute of Medicine (IOM), Washington, DC, 3-4th March, 2016

Drs. Richard Keefe and Atul Pande co-chaired the 2-day public workshop that brought together stakeholders from technology companies, academia, NIMH, large and small pharma, CROs, and perhaps most importantly, representatives from both US and European regulatory authorities.

Steve Romano, SVP/CSO of Mallinckrodt Pharmaceuticals and Shitij Kapur, Executive Dean at the Institute of Psychiatry, London, set the scene by detailing the challenges that the industry faces and why the status quo cannot continue. A host of prestigious academic and industry leaders described the search for biomarkers, the RDoC approach as an alternative to DSM for recruitment criteria, novel trial designs and innovative statistical approaches.

The afternoon session on Day 1, moderated by Amir Kalali, Head of the Neuroscience Center of Excellence at Quintiles, brought together key players at the forefront of technological innovation to discuss how the current boom in the consumer market for wearables and mHealth products will be a driving force for changing how clinical trials are conducted in the future: obtaining real-world data in large sample sizes outside of scheduled trial visits; continuous and passive data collection; and definition of novel endpoints that better reflect diseases progression and treatment effects. To capitalize upon these opportunities, the participants also addressed the accompanying challenges of privacy and data security, ensuring the validity and veracity of the data, and reducing the cost of conducting clinical trials in the future.

Day 2 began with an excellent regulatory session moderated by Thomas Laughren, former Director for the FDA Division of Psychiatry Products, with newly-appointed Commissioner of the FDA, Robert Califf, and Director General of the Italian Medicines Agency (AIFA), Luca Pani. Speakers emphasized the need to design clinical trial programs with the product label and clinical practice guidelines in mind, because regulators want to see how an approvable drug fits in the marketplace, both in terms of clinical benefits and comparative effectiveness. Dr. Pani also provided a national payer’s perspective, with a fascinating insight into the AIFA process for reimbursement negotiations, that was supplemented in the afternoon by discussions regarding real world outcomes as the basis for drug pricing and reimbursement. .

In closing a very engaging two days, Dr. Keefe summarized the key take-home messages: we must find a new way of conducting neuroscience trials because the current model is not sustainable. The new and disruptive technologies offer up methods of data collection that have not been available to us before. These methods hold promise not just for clinical trials, but as ongoing methods of patient engagement and obtaining real-world treatment data that will help to address increasing need for comparative effectiveness for regulators and payers. The challenge however, is assuring that we apply the appropriate level of rigor to these new opportunities, so we can be confident that the decisions we make are based not on hope and marketing, but on good science. . And that was the strong message from the regulators: they are open to new methods, new technologies, and new outcomes, but to consider them, we must ‘show them the data’.